SUMMARY PROJECT FICHE

Transcription

1 2002 SUMMARY PROJECT FICHE 1. Basic Information 1.1 Désirée Number: 1.2 Title: Upgrading of the State General Laboratory 1.3 Sector: Internal Market, Environment, Agriculture 1.4 Location: Ministry of Health / State General Laboratory, Nicosia - Cyprus 2. Objectives 2.1 Overall Objective(s): The full implementation of the relevant EU legislation, with the view to protect the consumers health and the environment, and to ensure Cyprus integration to the internal market. 2.2 Project purpose: This project aims to support the upgrading of the State General Laboratory (SGL) in order to be able to implement effectively the EU legislation regarding the official controls of foodstuffs, pharmaceuticals, cosmetics, environment (water), toys, veterinary drug residues, plant health (pesticide residues) and plant hygiene (contaminants) and to support the SGL in maintaining the accreditation granted as well as in extending the scope of the accreditation. 2.3 Accession Partnership and NPAA priority Accession Partnership Free movement of goods Pursue alignment of remaining traditional sectoral legislation, in particular in the field of pharmaceuticals for veterinary use, cosmetics and foodstuffs. Reinforce horizontal administrative infrastructure and implementing capacity in the sectors covered by product specific legislation. Agriculture Continue alignment of veterinary and phytosanitary legislation and upgrade inspection arrangements. Environment Continue implementation of the acquis, with special emphasis on urban waste water treatment and packaging waste; develop an implementation plan for the Water Framework Directive. NPAA Free Movement of Goods-Foodstuffs Upgrading of existing equipment, as well as purchase of new equipment; Training of personnel on quality assurance issues, training of audit officers and training of personnel, which will be engaged in the implementation of the harmonized legislation. Free Movement of Goods-Cosmetics Training of personnel to be engaged in the implementation of harmonized legislation.

2 Environment Further strengthening of monitoring mechanisms. Agriculture-Veterinary The harmonization plan includes, purchase of the necessary equipment and securing personnel training. 2.4 Contribution to National Development Plan N/A 2.5 Cross Border Impact N/A 3. Description 3.1 Background and justification In Cyprus, the concept of implementation of the official control of foodstuffs, water etc. is based on the cooperation between Ministries or Departments concerned, through planning and implementation of effective monitoring programs. The State General Laboratory (SGL) has included a great part of its work in carefully prepared coordinating control programs, pilot projects on applied research, which ensure effectiveness and high-productivity and, when applicable, allow for multiple use of produced analytical data. The applied research undertaken by the SGL is prevention oriented and leads to the identification of problems and trends, their sources and etiology. It also produces reliable information to support decision making and public policies. In order to produce correct and reliable results and to apply, effective control, SGL implements a Quality Assurance program since 1991 and every year it designs training programs for the personnel on subjects related to its field of responsibilities. The SGL is a Department of the Ministry of Health. The SGL is not yet an accredited laboratory. It has applied for accreditation and it is expected to become accredited by 2002, on some methods of analysis. It is an obligation of the SGL to maintain the accreditation granted. The SGL will also extend the scope of accreditation to cover additional methods of analysis. A project has been already approved within the framework of the 2001 Programming of funds under the Pre-accession Regulation. It concerned the upgrading of the SGL in order to enhance its capacity to implement the acquis concerning official controls, and to comply with the requirements concerning the accreditation of laboratories (with regard to the specific methods of analysis for which it aims to be accredited by 2002). The 2002 Project is a continuation of the first project and the two projects have been designed in such a way so as to complement each other (see Annex 4: List of equipment). The upgrading of the SGL is nevertheless a continuous process, until the Laboratory reaches the level that will allow it to implement fully and effectively the acquis regarding official controls. The Project for 2002 Programming aims to further support the upgrading of the State General Laboratory so as to improve its performance, which is necessary for the fulfillment of the priority needs identified through screening process and, therefore, to achieve effective implementation of the EU legislation. More specifically, this project aims at satisfying the requirements of the acquis with reference to: Foodstuffs: Directives 89/397/EEC, 93/43/EEC, 93/99/EEC and all relevant Directives/Regulations.

3 Materials and articles intended to come into contact with Foodstuffs: Directives 84/500/EEC, 82/711/EEC, 90/128/EEC and all relevant Directives. Pharmaceuticals: Directive 65/65/EEC. Safety of Toys: Directive 88/378/EEC. Veterinary Drug Residues: Regulation 2377/90/EEC and Directives 93/23/EC and 93/22/EC. Environment-Water: Directives 80/778/EEC, 98/83/EC and all relevant Directives; Agriculture-Plant Health: Directives 86/362/EEC, 86/363/EEC, 76/895/EEC; Plant Hygiene: Regulation 194/97/EC and Directive 315/93/EEC. With the 2002 Project, the process of harmonisation of the SGL capacity in the above mentioned areas will be completed. Within the framework of the harmonisation process, measures which have been introduced with relation to the SGL activities are shown in the Appendix. Moreover, this project aims at the further enhancement of the capacity of SGL to implement the EU legislation effectively (and thus satisfy all the requirements of the relevant directives), as well as to maintain and to extend the scope of accreditation in order to cover more methods of analysis. 3.2 Linked activities: The SGL participates in European or other Inter-laboratory Quality Control programs (FAPAS, GEMS) and in European and international research programs (LIFE, UNOPS). Within the 2001 Programming of the funds under the Pre-accession Regulation, a project has been approved regarding the upgrading of the SGL in order to enhance its capacity to implement the acquis concerning official controls and to comply with the requirements concerning the accreditation of laboratories with regard to the specific methods of analysis it aims to be accredited by The aim of the two projects (2001, 2002) is to achieve this objective and therefore to satisfy the quality system s requirements and the requirements of the EU legislation regarding, frequency of sampling, number of parameters (including new) number of samples etc. 3.3 Results: Upgrading the State General Laboratory SGL personnel trained on additional methods of analysis, operation of high-technology equipment; Laboratory equipment and hardware equipment operational, in order to support the SGL to carry out effectively its functions. 3.4 Activities: In order to prepare the SGL for full implementation of the EU legislation related to Free Movement of Goods (foodstuffs, veterinary drug residues, pharmaceuticals, safety of toys), Environment (water) and Agriculture (plant health pesticide residues; plant hygiene contaminants in foodstuffs), the SGL needs to train its personnel on the implementation of new methods of analysis, on the operation of new high-technology equipment and to purchase equipment.

4 This should be done with a view to fulfill the EU requirements regarding the official controls (frequency of sampling, number of samples, number of parameters, quantitative determinations), as well as to enhance its hardware infrastructure in order to follow efficiently the procedures required by norm EN The two components of the project, training courses and the purchase of instruments, aim, not only to strengthen the capacity of SGL to implement the EU legislation effectively and thus satisfy all the requirements of the relevant directives, but also to maintain and to extend the scope of accreditation to include more methods of analysis. This project will therefore include the following activities: 1. Training courses on the operation of new high-technology equipment and on new methods of analysis: (ANNEX 5) Personnel, from 11 different Laboratories dealing with the analysis of foodstuffs, consumer products etc, will be trained on the application of various methods of analysis, the use of new high technology instruments etc. The training courses on methods of analysis relate to: the application of new techniques which require extensive training (e.g. use of Nmr in the determination of the authenticity of foodstuffs), the determination of new parameters for which clarifications are required regarding the application of the method and the quality control, the validation of methods which are included in the plan for extending the scope of accreditation. 2. Purchase of necessary equipment (for specifications see ANNEX 4): - Equipment for the control of Foodstuffs, Veterinary drug residues, Materials and articles intended to come into contact with foodstuffs, Safety of toys, Environment-water/air pollution/wastes, Plant health-pesticide residues and Plant hygiene-contaminants in foodstuffs (GC s, GC-MS, HPLC s, accessories for GC-MS, GC-autosamplers, HPLC MS etc). The instruments which will be purchased are required for the determination of new parameters but mainly for the confirmation of results. - Computer hardware in order to strengthen the hardware capacity of the SGL. Eleven computers will be purchased intended for the 11 laboratories, which, by the year 2002 are expected to become accredited. The laboratories are now equipped with computers which do not satisfy the needs (1.2 Gbites, 100MHz). The computers are used for Laboratory Information Management Systems (LIMS), generation of test reports, control of inventories, stock control of reagents and standard material and word processing. The SGL has developed systems for all the above procedures and it is imperative that the laboratories are equipped with state-of-the-art computers to ensure proper and safe use of these systems. 4 Institutional Framework The State General Laboratory (SGL) is a department of the Ministry of Health. It is the competent laboratory for chemical and microbiological analysis of foodstuffs, water, pharmaceuticals, environmental samples and other consumer products, and is an implementing, controlling and applied research institution, its main objectives being the protection of public health, of the environment, of the trade and, generally, of the national economy. It comprises six sections with 18 Laboratories (13 chemical, 3 microbiological, 1 virology, 1 ecotoxicology) all equipped and staffed with well-qualified and trained personnel, an IT unit and a Quality Assurance Unit. The department has 56 qualified staff. The State General Laboratory will support the implementation of the proposed project by assuring the necessary organizational environment, making available the necessary personnel, necessary infrastructure and related running and administrative costs.

5 5 Detailed Budget Component 1. Upgrading strengthening of the State General Laboratory Investm ent (1) Institution Building (2) Total EU financing (=I+IB) (million EURO) National IFI TOTAL Co-financing (3) Total (1) - In relation to equipment, software, documentation and related services (installation, testing, training etc.); (2) - In relation to training, changes in organization, procedures, legislation, etc. (3) In relation to the purchase of other related equipment and to the running cost of the project. 6 Implementation Arrangements 6.1 Implementing Agency The State General Laboratory (SGL) within the Ministry of Health will be the Implementing Agency for the project. A Project Steering Committee (PSC) will be set up, comprising senior representatives of the SGL and the Planning Bureau. The PSC will supervise and co-ordinate the overall progress and implementation of this project component, will define priorities, will provide guidance and will approve the results. The PSC will be chaired by the Director of the SGL. 6.2 Twinning N/A 6.3 Non-standard aspects N/A 6.4 Contracts The project will be implemented through one service supply contract awarded through an open tender procedure. Such an approach will maximize the effectiveness and the coherence of the project activities, will facilitate the co-ordination, will produce economies of scale and will reduce the administrative burden. 7 Implementation Schedule The Terms of Reference for the above mentioned project components, as well as the Tender Dossier will be prepared in advance by the State General Laboratory in accordance with the DIS requirements. 7.1 Start of tendering/call for proposals: February Start of project activity: Sept Project Completion: March 2004

6 8 Equal Opportunity Article 28 of the constitution safeguards the right of all persons to equality before the law, the administration and justice and of equal protection there of and treatment thereby. Any direct or indirect discrimination against any person on the ground, i.a., of his sex, is prohibited. Furthermore, the prevailing legislation with respect to equality of treatment for men and women is partly in conformity with the Acquis Communautaire. The following laws currently in force in Cyprus cover equality issues: the equal Pay between men and women for Work of Equal Value Law (Law 158/89), the Protection of Maternity Law of 1997 (Law 100(1)/97), the Termination of Employment Law 1967 (Law 24/67) as amended, and the Commissioner for Administration Law 1991 (Law 3/91) as amended. Cyprus has ratified by Law 39/62 the European Convention for the Protection of Human Rights and fundamental Freedoms. Various International Conventions, which guarantee equal rights between men and women, have also been ratified. The State General Laboratory (SGL) is an equal opportunity employer. The human resources of the SGL in terms of personnel comprise 9 men and 69 women. The director of the SGL is a woman. 9 Environment N/A 10 Rates of return N/A 11 Investment criteria N/A 12 Conditionality and sequencing The legislation of a given sector must have been transposed before the investment in equipment for this sector can start. The components of the project are inter-related and adopt a logical approach to design and implementation. There is a strong linkage between project fiche 2001 and project fiche ANNEXES TO PROJECT FICHE 1. Logical framework matrix in standard format 2. Detailed implementation chart 3. Contracting and disbursement schedule by quarter for full duration of programme 4. List of equipment 5. Training Courses

7 ANNEX 1 LOGFRAME PLANNING MATRIX FOR PROJECT: UPGRADING OF THE STATE GENERAL LABORATORY Contracting period expires: 31/07/2004 Disbursement period expires: 31/07/2005 Total Budget: 1,5 M Phare budget: 0,7 M Overall Objective Objectively Verifiable Indicators Sources of Verification The full implementation of the relevant EU legislation, with the view to protect the consumers health, the environment, and to ensure Cyprus integration to the EU internal market. Full preparation of Cyprus at the time of accession; Exports of products to the EU ensured. European Commission s Opinion on the Status of Preparation of Cyprus for Accession. Screening reports. Project Purpose Objectively Verifiable Indicators Sources of Verification Assumptions To support the State General laboratory to fully implement the EU legislation regarding the official controls and to maintain the accreditation granted as well as to extend the scope of accreditation. Harmonised and effective official controls Maintain accreditation Extend the scope of accreditation Regular reports to the Commission. Certificates of Accreditation. Commitment to EU continued. National legislation fully harmonised and implemented.

8 Results Objectively Verifiable Indicators Sources of Verification Assumptions SGL personnel trained on additional methods o The official control implemented analysis, operation of high-technologyy effectively. equipment; Trained personnel in place. Laboratory equipment delivered and operational Laboratory equipment delivered Hardware equipment supporting SGL to carry and in current use. out effectively its functions, delivered and operational. Accreditation body Regular reviews by representatives of the European Commission. Regular department reports. Certificate of Accreditation Adequate provision from the national budget. Activities Means Source of verification Assumptions Training of the personnel on implementation of new methods of analysis and on the operation of new high-technology equipment. Purchase of necessary equipment Service procurement contract awarded as result of opening tender procedures. Full commitment of the involved authorities; Effective monitoring of project implementation; Timely availability of adequate resources. Preconditions Political commitment for EU accession. Budgets approved and available.

9 Annex 2 DETAILED TIME IMPLEMENTATION CHART FOR THE PROJECT COMPONENT Upgrading/strengthening the State General Laboratory O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J D D D D D D C C C C C C I I I I I I I I I I I I I I I I I X D = Design C = Contracting I = Implementation X = Closure

10 Annex 3 CUMULATIVE CONTRACTING AND DISBURSEMENT SCHEDULE All figures in million EURO 31/12/01 31/03/02 30/06/02 30/09/02 31/12/02 31/03/03 30/06/03 30/09/03 31/12/03 31/03/04 30/06/04 CONTRACTED 0,70 DISBURSEMENT NB: 1. All contracting should normally be completed within 6-12 months and must be completed within 24 months of signature of the FM. 2. All disbursements must be completed within 36 months of signature of the FM.

11 ANNEX 4 DETAILED SPECIFICATIONS OF EQUIPMENT TO BE PURCHASED Laboratory New Equipment Project fiche 2001 New Equipment Project Fiche Estimated cost (EUR) Food Additives Adulteration and Special Analysis of food Lab. 13 Food Composition and Food Quality Nutritional value Lab. 1 Veterinary drug Residues Lab. 5 Control of Radio nuclides Lab. 9 1 autosampler for HPLC 1 computer control processor 1 In line degasser 1 Water bath 1 system suitability for HPLC 1 Gas Chromatograph 1 Autosampler for Nmr 1 PCR 1 Software for SNIF Nmr 1 Alliance system / computer program for data processing 1 a-counter 1 ß-Counter electron deposition system 1 Fluoremeter 1 distillation /titration unit for N- determination 1 LC-MS 1 balance (5dp) 1 balance (2dp) Control of Pharmaceutical products and cosmetics Lab. 4 1 Gas Chromatograph - Environmental and other Food Contamination Natural toxins Lab.14 Pesticide Residues Lab. 8 1 HPLC / fluorescence / conductivity 1 Computer Control processor 1 Post column derivatization pump 1?n line degasser 1 system suitability for HPLC 1 GC / autosampler / homogenizer 1 autosampler and data processor for GC 1 Gas Chromatograph MS ion trap detector Environmental Chemistry Lab. 6 Accessories for GC MS 1 Integrator software with GLP for GC 1 auto sampler for GC Environmental Chemistry II and 1 HPLC / Fluorescence / UV - control of effluents Lab. 10 Materials and Articles in contact with food and safety of toys Lab. 12 Equipment for testing the mechanical properties of toys 1 GC-MS 1 balance (4dp) Water Microbiology Lab.15 - Colilert sealer 1204 Food Microbiology 16-1 vortex balance (2dp) 1204 Information Technology Unit - 11 computers National co-financing (EUR) 797,736

12 Project Fiche 2001 Laboratory Environmental and other food Contamination, Natural Toxins - Lab. 14 Food additives and adultaration - Lab. 13 EQUIPMENT FOR REPLACEMENT Equipment 1 fluorescence detector for HPLC 1 fluorometer 1 Isoelectric focusing apparatus (electrophoresis) Project Fiche Food Composition - Lab. 1 1 oven 1 Hydrogen Generator 1 GC General water examination - Lab. 2 1 flame photometer - - Articles in contact with food and safety of toys - Lab.12 Environmental Chemistry II and Control of Effluents Lab FTIR - 1 Ion-chromatography system - Control of pharmaceutical products and cosmetics - Lab. 4 1 sonicator 1 oven - Veterinary drug Residues - Lab.5 1 GC-MS - Environmental Chemistry I Lab. 6 1 freezer - Pesticide Residues Lab. 8 1 hydrogen generator - 1 air compressor 1 vacuum pump 1 sample homogenizer (a) 1 sample homogenizer (b) 1 Analytical balance (5dp) 1 Balance (2 dp) 1 freezer Water Microbiology Lab.15 1 incubator - Food Microbiology 16 1 freezer - Forensic Science & Toxicology Lab. 3 1 GC -

13 ANNEX 5 TRAINING TO BE ORGANISED INCLUDING DURATION AND No. OF TRAINEES Laboratory /Training Course No of Trainees/ Duration (weeks) 1) New trends in planning, implementing, and evaluation of analytical work in EU Laboratories. Director/Senior Analyst 1 week 2) Food additives adulteration and special analysis of food (Laboratory 13) Analysis of food additives concerning purity criteria. 1/1 3) Food composition and Food Quality, Nutritional value. (Laboratory 1) a) Determination of the authenticity and adulteration of foodstuffs using new spectroscopic techniques (NMR, SNIF NMR, FTIR) and statistical analysis (Chemometrics) 1/3 b) Essential Composition of foods for vitamin and trace elements. 1/2 4) Control of Industrial product (Laboratory 11) 1/2 Safety of household Chemicals Consumers protection 5) Veterinary drug residues (Laboratory 5) a. Determination of NSAID (corticostiroides) residues in meat and milk 6) Foodstuffs-Microbiology (Laboratory 16) a) Examination of fishery products for Vibrio spp. Confirmatory techniques for Vibrio Choleral, Vibrio parahaemolyticus and Vibrio Vulnificus b) Advanced and new techniques in Food Microbiology c) Methods in Virological examination of foodstuffs (esp hepatitis A) Possibilities and Prospects 7) Control of Pharmaceutical Products and Cosmetics (Laboratory 4) Medical devices and FTIR technique for the purity of the active ingredients in pharmaceutical preparations. 1/1 1/1 1/2 2/3 1/1 13

14 Laboratory /Training Course 8) Environmental and other Food Contamination Natural toxins (Laboratory14) Analysis and method validation of ochratoxin A and monochloropropanediol in foods 9) Pesticide Residues (Laboratory 8) No of Trainees/ Duration (weeks 1/1 1/2 HPLC-MS of pesticide residues 10) Environmental Chemistry (I) and Exotoxicology (Laboratory 6) a) HPLC-MS Environmental Applications b) Training in Ecotoxicology 11) Water Microbiology (Laboratory 15) Isolation and identification of parasites (Giardia, Cryptosporidium from water samples) 12. Forensic Science and Toxicology (Laboratory 3) 1/2 1/2 1/1 1/2 Training on the analysis of new narcotics and precursors of these illegal substances. 14

15 APPENDIX National Legislative measure EU Legislation Enactment Date FOODSTUFFS The Materials and Articles intended to come into Contact with Foodstuffs Regulations (P.I. 120/1999) Directives 89/109/EEC, 78/142/EEC, 80/766/EEC, 81/432/EEC, 82/711/EEC, 85/572/EEC, 90/128/EEC, 84/500/EEC, 93/10/EEC, 80/590/EEC, 93/11/EEC Date of entry into force 2/6/ /12/1999 The Food (Control and Sale) of 2001 (Law 40(I)/2000) Hygiene and Official Control of Foodstuffs Regulations of 2001 (PI 143/2001 The Colouring matters in foodstuffs Regulations The sweeteners in foodstuffs Regulations The labeling of food Additives in foodstuffs Regulations 89/397,93/99,98/28 93/6. 89/397, 93/43,93/6, 98/28, 93/99 94/36 95/45 99/75 94/35 96/83 95/31 98/66 89/107 22/3/ /3/ /9/ /4/ PHARMACEUTICALS The Medicinal Products for human use (Quality, Supply and Pricing Control) Law of 2001 ENVIRONMENT-WATER New Law on the Quality of Drinking Water Directive 65/65/EEC 19/4/ /05/2001 Directives 76/895/EEC, 86/362/EEC and 86/363/EEC 19/04/